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Effect of resilience education on improving the ability to cope with stress and hope of mothers of children with cancer: a before-after clinical trial

Protocol summary

Study aim
To assess the effect of resilience education on improving the ability to cope with stress and hope of mothers of children with cancer
Design
This is a before-after clinical trial without control group, in which eligible mothers will be studies both before and after the intervention.
Settings and conduct
This study will be performed in the Besat Hospital in Hamadan city on 60 mother of children with cancer. Eligible mothers will be assessed both before and after the intervention. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 50 years Having a child with cancer Being literate Exclusion criteria: Failure to attend classes for more than 2 sessions
Intervention groups
Intervention group: Resilience training for 60 minutes once a week for 9 sessions (including the concept of resilience, the characteristics of people with high resilience such as happiness, wisdom and insight, humor, sympathy, intellectual adequacy, purposefulness in life, and stability; internal and external factors affecting resilience such as optimism, self-esteem, social support, and individual responsibility; ways to increase resilience such as establishing and maintaining relationships with others, acceptance, self-awareness, purposefulness and hope for the future, developing self-confidence, and self-care) Control group: In comparison with before intervention
Main outcome variables
Primary outcome: Stress score, the hope score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N478
Registration date: 2023-07-27, 1402/05/05
Registration timing: prospective

Last update: 2023-07-27, 1402/05/05
Update count: 0
Registration date
2023-07-27, 1402/05/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of resilience education on improving the ability to cope with stress and hope of mothers of children with cancer: a before-after clinical trial
Public title
Effect of resilience education on improving the ability to cope with stress and hope of mothers of children with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years Having a child with cancer Being literate
Exclusion criteria:
Failure to attend classes for more than 2 sessions
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.UMSHA.REC.1402.288

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

Primary outcomes

1

Description
Stress score
Timepoint
Before the intervention and 2 months later
Method of measurement
Using the Parental Stress Questionnaire

2

Description
The hope score
Timepoint
Before the intervention and 2 months after
Method of measurement
Using the Parental Hope Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Resilience training for 60 minutes once a week for 9 sessions (including the concept of resilience, the characteristics of people with high resilience such as happiness, wisdom and insight, humor, sympathy, intellectual adequacy, purposefulness in life, and stability; internal and external factors affecting resilience such as optimism, self-esteem, social support, and individual responsibility; ways to increase resilience such as establishing and maintaining relationships with others, acceptance, self-awareness, purposefulness and hope for the future, developing self-confidence, and self-care)
Category
Treatment - Other

2

Description
Control group: In comparison with before intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Mohammad Ghiasvand
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
mohammad.ghiasvand9877@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Ghiasvand
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mohammad.ghiasvand9877@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpoor
Position
PhD in Health Information Management
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mohammadpour@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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